In the phase I/II clinical trial, patients received MDX-010 every three weeks, plus high dose IL-2 therapy. Study results show that eight of 36 patients with metastatic melanoma experienced objective clinical responses.
Of the eight patients who experienced objective tumor regression, two patients in the 3mg/kg cohort experienced complete responses that are ongoing at over 13 months, and one patient in the 2mg/kg cohort experienced a complete response that is ongoing at over 16 months. Five patients experienced partial responses, with responses ranging from seven months to the longest duration ongoing at over 19 months.
Five patients in the clinical study reported grade III/IV adverse events, including colitis and uveitis, that were consistent with the immune-based mechanism of action, as well as pancreatitis, arthritis and laryngospasm.